• QA QMS Associate

    Actalent (Fall River, MA)


    Job Title: QA QMS Associate

    Job Description

    The QA QMS Associate is responsible for ensuring compliance with both internal and external quality standards, playing a pivotal role in maintaining and enhancing the Quality Management System (QMS) in accordance with Good Manufacturing Practice (GMP) and regulatory requirements.

    Responsibilities

    + Assist in the development, implementation, and maintenance of the QMS in line with GMP and regulatory requirements.

    + Maintain and ensure proper documentation of all quality systems and records.

    + Oversee document control processes, ensuring SOPs, work instructions, and other quality documents are up to date and correctly implemented.

    + Assist in the collection, analysis, and reporting of quality data, including quality metrics, CAPA reports, and audit findings.

    + Support investigations of deviations, non-conformances, and customer complaints, ensuring appropriate follow-up and resolution.

    + Provide training and guidance to employees on QMS-related processes and regulatory requirements.

    + Ensure compliance with all regulatory requirements.

    + Support risk assessments and help mitigate potential quality risks to product safety and compliance.

    + Familiarity with pharmaceutical operations, preferably MDI, to ensure required compliance.

    + Familiarity with TrackWise applications for handling Deviation and CAPA.

    + Prepare and review investigations related to deviation, OOS, market complaints, and microbiological failure.

    + Prepare and review trends related to various QMS elements like Deviations, CAPA, Change Request, and Environmental monitoring.

    + Preparation and review of the Annual Product Quality Review.

    + Fulfill the requirements of regulatory submission while closely working with regulatory teams.

    + Prepare and review risk assessments (FMECA) for various facilities, equipment, processes, and particular events.

    + Prepare and review elemental impurities risk assessment and nitrosamine-related risk assessment.

    + Prepare audit reports, document findings, and provide actionable recommendations for improvement.

    Essential Skills

    + Quality auditing

    + Quality assurance

    + Quality management system

    + GMP

    + Batch record review

    + Deviation investigations

    + Out of Specifications (OOS)

    + Out of Trends (OOT)

    + CAPA

    + Change control

    Additional Skills & Qualifications

    + Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field from an accredited institution.

    + Bachelor's degree in a scientific discipline such as biology, chemistry, pharmacy, or related field is preferred.

    + Minimum of 3 years of experience in MDI or combination products is preferred.

    + Proficient in Microsoft Office tools, SAP, and other business applications.

    + Ability to influence decision-making and facilitate completion of work towards achieving business goals.

    + Effective interpersonal relationship skills and ability to work in a team environment.

    + Proficiency in English, including usage, spelling, grammar, and punctuation.

    + Current Good Manufacturing Practices (cGMP) knowledge.

    + Self-starter demonstrating initiative with seeking additional training or direction.

    + Strong organization and leadership skills, both written and verbal.

    + Detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

    Work Environment

    You will be working with a small team of 15 people in the quality department, with significant cross-collaboration with different departments. This role operates on a first shift from 8:00 am to 5:00 pm, Monday to Friday.

     

    Company is offering up to 6K for relocation

    Pay and Benefits

    The pay range for this position is $74000.00 - $95000.00/yr.

     

    Will Sponsor OPT-H1BRelocation Assistance up to $6,00010% annual bonuses based on fiscal yearHealthVisionDental401K

     

    Workplace Type

     

    This is a fully onsite position in Fall River,MA.

     

    Application Deadline

     

    This position is anticipated to close on Aug 11, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.